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Quality Systems Associate

3 months ago

Stillwater, United States DiaSorin Full time
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
Why Join Diasorin?
  • Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
  • Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact

Job Scope:

*Participating in the design, creation, and implementation and monitoring of programs and methodologies to ensure that Luminex products meet established specifications, design criteria, quality standards and customer requirements.

*Sharing responsibility for Quality Assurance operations associated with Luminex products and processes.

*Thorough knowledge of the Luminex Quality Management System is essential to competently fulfill the duties of the position.

Key Responsibilities and Duties

  • Review and approve manufacturing records (includes all manufacturing department BPRs) and QC Records (department tests and inspections)
  • Review and approve Device History Records
  • Release products for distribution.
  • Review Product Lot Request records
  • Review and approve pilot lots
  • Participate in performing CAPA effectiveness checks, CAPA follow-up and ANR follow-up
  • Review and approve ECOs and DCOs as assigned
  • Log, file, maintain and archive various QA records
  • Prepare materials for QA meetings and, as assigned, present materials at QA meetings.
  • Coordinate resolution of quality issues with internal personnel and departments
  • Participate in audits and inspections
  • Support and participate in other QA related activities as required.
  • Other duties as assigned.

QUALIFICATIONS

  • Bachelor's degree in a life science or engineering or equivalent related experience
  • 1+ years Experience in Quality Assurance activities
  • Experience with participating in formal audits
  • Experience in Medical Device Manufacturing environment
  • Knowledge of cGMP regulations (21 CFR 820, CMDR and ISO 13485)
  • Detail oriented
  • Competency in use of Microsoft Excel, Word and Outlook
  • Excellent interpersonal, communication and organizational skills.

What we offer:

  • Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at or to request an accommodation.
The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.
Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.
This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

This contractor and subcontractor shall abide by the requirements of 41 CFR a), 41 CFR a) and 41 CFR a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.